# K972160: CRP-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex Test

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Laboratories, Inc.
- Decided: Aug 1, 1997 after 53 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CRP-LEX-SYSTEM is intended to be used in hospital and other appropriate clinical laboratories, to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/dl) concentration. The CRP-LEX method is by latex slide agglutination. At CRP levels at or above this noted concentration, agglutination of the CRP-LEX latex particles should be observed. A screening (qualitative) and semi-quantitative procedure (dilution of the patient specimen) has been included and described.

Source page: https://510kreport.com/device/K972160
Methodology: https://510kreport.com/methodology